Effects of a Glucoside- and Rutinoside-rich Material in Chemotherapy-induced Peripheral Neuropathy and Related Symptoms

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    246
  • sponsor
    Taipei Medical University
Updated on 29 January 2021

Summary

Chemotherapy-induced peripheral neuropathy (CIPN is common among cancer patients during or after chemotherapy, and the currently available drugs cannot effectively manage the symptoms. Besides, CIPN causes fatigue, anxiety, and depression. CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. We plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

Description

Cancer is at least partially attributable to immunological disturbance, and its treatment causes additional inflammatory problems. Chemotherapy-induced peripheral neuropathy (CIPN), especially that induced by oxaliplatin or Taxanes (including paclitaxel and docetaxel) is common among cancer patients during or after the treatment of chemotherapeutic agents, presented as pain and sensory abnormalities for months, and even persists for years in some patients after the cessation of chemotherapy. Even worse is that currently available drugs cannot effectively manage these conditions. Besides, CIPN causes fatigue, anxiety, and depression, which lower patients' quality of life and determination to fight the disease. Interestingly, CIPN is featured by the interference of interleukin (IL) pathways, among which escalation of IL-17 is predominant, suggesting that IL-17 may be manipulated to reduce the inflammation or the immunological disturbance. Cyanidin, a type of glucosides, has been proved to behave like an IL-17 inhibitor and works in an animal model of skin hyperplasia in reducing the IL-17 levels and severity of hyperplasia. We have identified a food material that contains large amounts of glucosides and rutinosides - mulberry juice. Preliminary findings of an ongoing human study of our team have provided statistical evidence that this crude material effectively relieves clinical symptoms of a disorder associated with inflammation features. The current proposal aims to explore the effect of this IL-17 inhibitor-rich material in CIPN and related symptoms. To avoid confounding effects from pain, we plan to divide the potential participants into severe pain and mild pain group to conduct two human studies. A single-blinded randomized controlled design is adopted to compare the effects of this crude material between the experimental group and the control group in (1) pain and CIPN of the severe pain participants and (2) fatigue, anxiety, and depression in the mild pain participants. IL and other immune markers will be tested as evidence of improvement of inflammation status. We expect a decrement in pain, CIPN, fatigue, anxiety, and depression severity with the intake of this IL-17 inhibitor-rich material among cancer patients undergoing chemotherapy.

Details
Condition Chemotherapy Induced Peripheral Neuropathy
Treatment Mulberry juice
Clinical Study IdentifierNCT04669977
SponsorTaipei Medical University
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are eligible for study 1 (ffects of mulberry juice on pain and CIPN
in participants with severe pain) if they have any cancer and are receiving
the oxaliplatin or taxanes (paclitaxel and docetaxel) containing regimen
weekly. Other inclusion criteria are (1) age 20 and <75 years; (2) performance
status (PS) 0-2 according to the Eastern Cooperative Oncology Group (ECOG)
scale; (3) life expectancy > 2 months. Visual analog scale (VAS) 4. Subjects
for study 2 (ffects of mulberry juice on fatigue, anxiety, and depression in
participants with moderate pain) must meet all criteria above with the
exception that the VAS should be <4\

Exclusion Criteria

Patients are excluded if they (1) are not communicable; (2) have received
radiotherapy within 4 weeks and cardiac dysfunction due to prior
anthracyclines; (3) have symptomatic brain metastasis, symptomatic fluid
retention, or severe comorbidities such as uncontrolled diabetes mellitus
severe hypertension or infection; (4) have psychiatric or social conditions
that would prevent compliance with treatment, follow-up or adequate informed
consent. Pregnant or lactating females are also ineligible
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